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The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.

NCT01071772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-06-09

No results posted yet for this study

Summary

Diabetes and Heart Failure are diseases with high morbidity and increased risk of death. Former investigations has shown that diabetes worsens the prognosis of heart failure. However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function.

Our hypothesis is that short term dysregulation affects left ventricular function and exercise capacity in insulin treated type 2 diabetics with and without heart failure.

To elucidate this hypothesis diabetic patients with and without heart failure will be investigated after overnight state of either high or normal blood glucose levels on two separate occasions. Metabolic and hormonal parameters will be measured. Systolic and diastolic cardiac function will be assessed, exercise capacity and post exercise regional myocardial tissue velocity as well as 6 minutes walk test will be investigated on both occasions. The study will be a randomized cross-over design.

Conditions

Interventions

DRUG

insulin

There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.

Sponsors & Collaborators

  • Danish Heart Foundation

    collaborator OTHER

  • Region midtjyllands sundhedsvidenskabelige forskningsfond

    collaborator UNKNOWN

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Hans Erik Boedker, Prof, MD · Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Denmark

Study Locations

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01071772 on ClinicalTrials.gov